Conservative non-pharmacological interventions in women with pelvic floor dysfunction: a systematic review of qualitative studies

Background Women’s adherence is essential to physiotherapeutic treatment of pelvic floor dysfunction, but its related factors are not usually considered in the development of treatment approaches. This study aims to understand how women with pelvic floor dysfunction experience pelvic floor conservative non-pharmacological treatment options. Methods A systematic review of qualitative studies. The electronic search was performed in MEDLINE/PubMed, CINAHL, Lilacs, SCOPUS, and Web of Science databases. Primary articles on qualitative methods focused on the experience of women regarding pelvic floor conservative non-pharmacological interventions, i.e., pelvic floor muscle training (PFMT), either associated or not with biofeedback, perineal massage, vaginal dilators, and others. A meta-aggregation was performed. Results It was included 22 manuscripts in this review. It was found seven studies about the use of vaginal devices, two about manual intervention and 14 studies on women’s experience with PFMT. The findings were synthesized as follows: I) women’s experience of manual interventions; II) women’s experience using vaginal devices changes according to health professional attitudes; III) women’s experiences using vaginal devices varied depending on their pelvic floor dysfunction; IV) reported side effects due to the use of vaginal devices; V) external factors influencing PFMT performance; VI) women’s perception of their own personal factors influencing PFMT performance; VII) PFMT characteristics influencing women’s adherence; VIII) strategies used by women to include PFMT in their routine. Conclusion Women’s experience with pelvic floor conservative non-pharmacological treatment options is a complex phenomenon that involves many more variables than simply personal aspects. This is a systematic review of qualitative studies registered in the PROSPERO (CRD42018080244).

to be the gold standard treatment for PFD, specifically for urinary incontinence (UI) and pelvic organ prolapse (POP) in women [2,3]. Other conservative nonpharmacological treatment options for PFD include electrical nerve stimulation, perineal massage, vaginal dilators and pessaries [4,5].
Women's adherence is an essential component to be considered during conservative non-pharmacological treatments for PFD [6]. Adherence and its related factors are not usually considered in the development of different treatment approaches, nor as a primary outcome measure in randomized controlled trials (RCT), which is the appropriate study design to determine the effectiveness of any pelvic floor conservative nonpharmacological interventions [7][8][9].
A recognized limitation of RCTs is they do not allow an understanding of women's experience with the intervention under investigation, nor aspects that may influence their adherence to treatment [9][10][11]. Thus, qualitative research aiming to understand the experience of women with conservative non-pharmacological treatments for PFD can fill this important gap [10]. To date, no specific systematic reviews about this important topic was found.
Thus, the aim of this study was to perform a systematic review of qualitative studies to answer the following question: how do women with PFD symptoms experience conservative non-pharmacological treatment options?

Methods
This is a systematic review of qualitative studies registered in the PROSPERO (CRD42018080244) which search was conducted in April 2020. The research was planned based on SPIDER: I) Sample-women with PFD symptoms; II) Phenomenon of Interest-conservative non-pharmacological treatment options (PFMT, vaginal dilators, biofeedback, perineal massage, pessary, and others); III) Design-qualitative research, thematic analysis, grounded theory, phenomenology; IV) Evaluation-women's experience; V) Research type-qualitative studies.
The inclusion criterion was original qualitative research regarding women's experience with pelvic floor nonpharmacological interventions. The exclusion criteria were: (1) not primary research; (2) quantitative or mixed methods studies; (3) studies about women's experience with the treatment of their partners or children; (4) studies that included either only men or both men and women. Although systematic reviews, quantitative and mixed methods studies were not included in this review, their references were examined to identify any additional study that meet the inclusion criterion.
The electronic search was conducted by one researcher (ACNLF). No limit was set for year of publication. The last search was performed in April 2020. The primary research was conducted in MEDLINE/PubMed, CINAHL, SCOPUS, Lilacs and Web of Science databases, and is summarised in Table 1. Sample ("pelvic floor dysfunctions" OR "lower urinary tract symptoms" OR "urinary incontinence" OR "anal incontinence" OR constipation OR "fecal incontinence" OR "pelvic organ prolapse" OR "sexual dysfunction" OR vaginismus OR dyspareunia OR "pelvic floor") Phenomenon of Interest (physiotherap* OR "pelvic floor muscle training" OR "pelvic floor exercise" OR "Kegel exercise" OR "behavioral treatment" OR "behavioral therapy" OR "perineal massage" OR "vaginal dilators" OR "vaginal cones" OR biofeedback OR "electrical nerve stimulation" OR "electrical stimulation" OR pessaries OR "exercise therapy" OR treatment OR therap*) Design ("qualitative research" OR "qualitative study" OR qualitative OR "thematic analysis" OR "grounded theory" OR phenomenology OR "focus group" OR "semi-structured interview")

Research type qualitative
The search result was imported to the EndNote online platform where duplicates were excluded. The remaining references were first selected according to the relevance of their title and abstract to the research question. The selection was conducted by two independent researchers (ACNLF and TBD) who carefully read the full texts. Any disagreement was solved by discussion with a third reviewer (DPC). A secondary search was conducted manually using the selected articles and the reviews and mixed-method studies found during manual searching.
One researcher (CCP) was responsible for extracting the following information: bibliographic details, population, setting, cultural information, aims of the study, specific qualitative methodology, sampling method and size, and main results. Data synthesis was conducted after data extraction and fragments of participant reports was used to support the finding of this review. A second researcher (ACNLF) checked the extracted information as well as the congruence between the findings and the text fragments used. Divergences on selected information were settled through discussion between researchers.
The quality of the selected studies was assessed based on the quality criteria for qualitative studies, the Critical Appraisal Skills Programme checklist. This 10-question checklist covers three broad issues, named: are the results of the study valid (Section A-questions 1 to 6)? What are the results (Section B-questions 7 to 9)? Will the results help locally (Section C-question 10)?
A meta-aggregation [12] was conducted as follows: (1) extraction of all findings (including narrative fragments and quotes); (2) developing categories; (3) developing synthesised findings. Findings and categories were grouped based on similarity of concept and no software was used.

Synthesis of the results
The synthesis of qualitative results is presented as follows: I) women's experience of manual interventions; II) women's experience using vaginal devices changes according to health professional attitudes; III) women's experiences using vaginal devices varied depending on their pelvic floor dysfunction; IV) reported side effects due to the use of vaginal devices; V) external factors influencing PFMT performance; VI) women's perception of their own personal factors influencing PFMT performance; VII) PFMT characteristics influencing women's adherence; VIII) strategies used by women to include PFMT in their routine. Narrative fragments of the findings are presented in Table 2.

Synthesised findings I: Women's experience of manual interventions
Women undergoing physiotherapeutic treatment involving perineal massage to treat painful sexual complaints reported its deep impact on a physical, emotional and social level [15,26]. They reported health professionals' attention as careful, and they felt that their complaints were taken seriously. The treatment makes them have a better perception of their body sensations, as well as the feeling of great relief while muscle spasms decreased ( Table 2-Q.1, Q.3). All women reported feeling "better and better" after treatment.

Synthesised findings II: Women's experience using vaginal devices changes according to health professional attitudes
The studies presented the experience of women who had undergone pelvic radiotherapy [21,31], as well as women diagnosed with vaginismus [25], POP or UI [16][17][18][19]. Although there are differences in the studied sample, a common point needs to be highlighted: the communication between health professional and patient. The communication aspect of the treatment seems to have a negative influence on women's experience using vaginal dilators, while it has a more positive impact during the use of pessaries (Table 2-Q.4).
Women seems to become insecure using vaginal dilators [21,25,31] due to conflicting information offered by health professionals with different levels of communication skills, however, some women described that health professional support was essential to providing a good experience during treatment [16][17][18][19]. Poor interaction between health professionals and patients was reported as a reason for discontinuation of treatment (Table 2-Q.5).

Synthesised findings III: Women's experiences using vaginal devices varied depending on their pelvic floor dysfunction
For some women, using vaginal devices was simply an aspect of their treatment to reduce discomfort with their symptoms (Table 2- Despite some women with vaginismus reported a positive experience, most of them described it as "painful", "humiliating" and even "traumatic". The smallest vaginal dilator was considered too big, leading women to seek alternatives  Table 2 Synthesised findings and narrative fragments regarding women's experience with vaginal devices, manual interventions and PFMT

Treatment category Synthesised findings Narrative fragments
Manual interventions Women's experience of manual interventions Q.1: "Um, obviously it did feel as though someone was right inside so, when they were pushing down on it, obviously, it hurt. But, after, like, I think it was her thumb or her finger that had been there for ages, it would release off and then you couldn't feel anything. " [26] Q.2: "…It feels loads better now. I've only been, like, three, about three or four times, but it just feels loads different already. " [26] Q.3: "It was helpful because it was very educational how much your muscles will tense up as a result of painful sex or actual pain […] You could see the activity of the muscles, [what] the tone of your muscles was, so if they were tight, you could see that on the screen and then see when you're relaxing them […] you see it happening and so as a result you're in better control of it. " [15] Vaginal devices Women's experience using vaginal devices changes according to health professionals' attitudes Q.4: "Here they've given me information. How to put it on, how to take it off, and everything. I felt better. " [16] Q.5: "They sent me to see this lady to fit some sort of contraption, and she brought out this dice which was about two inches square…block on a string, and she spent 15 min writhing and tugging and trying to get it there, gave up and said, do it yourself. So I had a go, and I said, there's no way that is going to fit in there. Well, she said, you've had two babies. I said, yes, I have, I said, but your bones soften and everything's different, your physiology's different when you're having babies. I said, that's not going to go in there, and if it does go in there, it ain't going to come out, so I'm not using it. " [19] Q.6: "You lie down in a specific position that makes you feel quite vulnerable, and there is a doctor standing at the opposite end of you and she is trying to stick her finger in you [both laugh]. And then it doesn't go in and she is saying 'Relax. Relax. Relax. '" [25] Women reported varied experiences using vaginal devices depending on their pelvic floor dysfunction Q.7: "I just looked at it as a furthering of the treatment basically. " [31] Q.8: "The idea repulsed me a little. Well maybe because, just after that operation and brachytherapy and such, the medical world frequently inserted all kinds of objects [vaginally], and that made you feel like: not now. " [21] Q.9: "I did feel a little scared of having this [pessary] inside of me…I thought I was going to feel more uncomfortable than I was already feeling. But no, I eventually got accustomed to it. " [16] Q.10: "What do I like about my pessary? Well, it gives me more confidence that I can go out and be active. You know, it's bad always trying to be close to a washroom wherever I go. I'm very comfortable using it, it gives me some security that I can go out and enjoy myself, either to a party, or to our lunches or play darts or whatever. " [17] Side effects while using vaginal devices Q.11: "But it was also kind of scary [referring to blood loss during dilator use] (…)" [21] Q.12: "The only thing that I'd change is that I had some bleeding when I first used the dilator. It would have been nice if someone had warned me about this. " [31] Q.13: "Well, I perform... Yes, it's weird, but I perform dilator use while listening to music from Wagner. Because it is a music piece that lasts exactly 10 min. " [21] Q.14: "Those things [referring to dilators] aren't enjoyable sex toys. [...] Then I think: then you also have to pay for them as well.
[...] I also let them know that I found that very disturbing" [21] (e.g., vibrators and tampons). The transition between devices was difficult due to the jump in size. They stated that their journey would be easier if they cold count with partner, professional and peer support. In contrast, women using pessaries reported needing some time to learn how to use pessaries in an effective way, and once they learned how to manage it they perceived the treatment as a life-changing experience, using words such as "freedom", "security" and "satisfaction" ( Table 2-Q.9, Q.10).

Synthesised findings IV: Reported side effects due to the use of vaginal devices
Only studies on vaginal dilators presented reports of side effects, including blood loss, pain and vaginal discharge (Table 2-Q.11, Q.12). These negative experiences seem to result in anxiety, but also as a motivation to continue using dilators. Reported strategies to reduce negative feelings were increasing positivity and integrating the treatment into daily life, such as during a PFMT pelvic floor muscle training; Q quotes Strategies used by women to include PFMT in their routine Q.27: "Yeah yeah so the last thing I've been thinking about (laughter) is my pelvic floor exercises. " [33] Q.28: "I have a habit of touching my ear lobe each morning to remind myself of the things that I have to do… each day when I touch my earlobe, I will remember to do the exercise. I absolutely will keep on with it. " [30] bath (Table 2-Q.13). The sexuality involved in the use of the vaginal dilator was a controversial experience ( Table 2-Q.14).

Synthesised findings V: External factors influencing PFMT performance
The extrinsic factors appearing to influence PFMT performance are health care professional and family support (  16). For some women their complaints were not properly accept by some health professionals, and they felt the need for further instructions to be able to perform PFMT. These women complained that when they received the information it was not in an appropriate manner ( Table 2-Q.17). However, when the information and support were given properly, it helped them in adhering to PFMT.

Synthesised findings VI: Women's perception of their own personal factors influencing PFMT performance
This theme has three subthemes: Category I: Positive personal factors. A positive experience for women undergoing PFMT was reported as the feeling of control over their body (Table 2-Q.18). To avoid incorrect training, the ability to perceive and confirm their capacity to contract their PFM was considered important by women, in order to improve their commitment and confidence in their own ability to perform PFMT ( ; difficulties in PFMT performance, including the "invisibility" of the muscle; uncertainty whether or not they were correctly contracting their PFM (Table 2-Q.23); emotional, mood and climactic factors; guilty for not performing PFMT; worsening of the symptoms; loneliness while performing PFMT; perception that PFMT is boring or a waste of time; and the naturalisation of PFD symptoms.
Category III: Perineal perception. While some women reported an inability to perceive a correct PFM contraction, some highlighted that they could progressively perceive it and notice whether or not they were performing it correctly (Table 2-Q.24, Q.25).

Synthesised findings VII: PFMT characteristics influence women's adherence
Some women considered they have a better adherence to PFMT performed in groups, while others classified PFMT as a quiet, "private exercise" (Table 2-Q.26). While for some women PFMT could be done at any time of day without anyone else knowing, others emphasized their need to have a quiet place to focus on it. A positive point highlighted was the association of PFMT with other benefits, such as improving their self-confidence. The commitment involved in becoming a participant in clinical studies was perceived as one's own obligation to adhere to treatment. It is worth noting that PFMT was not seen as a "real exercise" by some participants (Table 2-Q. 26). This deconstruction of PFMT as physical exercise was justified by the anatomical region of the PFM, and by the possibility of performing contractions during penetrative vaginal sex.

Synthesised findings VIII: Strategies used by women to include PFMT in their routine
Some participants justified their lack of adherence to PFMT due to the lack of time to perform it. Other participants were able to include PFMT in their routine by associating it with daily life activities, such as performing the exercise while waiting for the bus or doing it every time they sit in their computer chair, among other situations (Table 2-Q.28). Table 4 shows that only four studies reported the use of any form of quality criterion and only one manuscript reported the use of the Consolidate Criteria for Reporting Qualitative Research (COREQ). Table 3 presents the studies' results of quality criteria analysis. Only six (26.1%) articles received the maximum score of section A, and 21 (91.3%) articles were considered to have clear (section B) or relevant results (section C). The quality of most included manuscripts was limited in aspects of methodology. There was a high number of manuscripts that did not present clear information about the recruitment strategies, nor regarding the relationship between the researchers and the participants.

Discussion
This study aimed to understand how women with PFD experienced pelvic floor conservative non-pharmacological treatment options. We included studies reporting women's experience with different conservative nonpharmacological options to treat PFD.
The experience of women with PFMT seems to be related to several personal factors. The understanding by physiotherapists of factors modulating the quality of    women's experiences with this intervention seems to be essential to improve it. Although the large amount of scientific evidence showing PFMT as a treatment for some PFD symptoms is well-established in the literature, adherence remains the most challenging aspect of this treatment [2,3,9,35]. PFMT adherence is a complex phenomenon that involves the active participation of patients. This study reinforces the need of women to receive further appropriate information to modify their behaviour, incorporating PFMT practice in their routine [9,35]. This perception is aligned with the results of studies showing women's general lack of knowledge related to PFM function, dysfunction and options of treatment, including PFMT [36]. Women with different background can acquire basic knowledge about PFMT after receiving information about the pelvic floor location/anatomy and PFM function [37].
Other studies have indicated that when women receive information about the pelvic floor they have a higher chance of adherence to PFD conservative interventions [6,8]. Still, many women consider they don't receive information based on their specific background and needs.
Another important aspect to be considered is women's belief in their ability to perform PFMT, commonly known as self-efficacy. This belief is the core of social cognitive theory, one of the many theories and methods described in the literature that can be used as a guide while working with health behaviour [6]. The use of a more patientcentred approach may improve not only self-efficacy but other personal factors as technical abilities that deeply influence women's experience with PFMT. Additionally, women referred to their ability to perceive or not perceive their PFM contraction, respectively, as a facilitator or barrier to PFMT. Self-perception as a modifier of PFMT adherence is an aspect which could be considered and worked on, as one study shows that women's estimation of their PFM contraction intensity is poor, especially in women with a non-contracting or a weak PFM [38]. An increase in women's perception of their PFM contraction seems to be another positive result of PFMT that could be further explored using a self-efficacy approach.
Similarly, to the strategies suggested to improve PFMT adherence, health behavioural theories have been used to identify and fill knowledge gaps related to continence promotion [39,40]. The study conducted by Chiarelli and Cockburn [39] identified, through focus groups, gaps related to women's knowledge after delivery and, using Health Belief Model as a theoretical guide, proposed an education program aiming to promote urinary continence (UI). To verify the program's effectiveness, a RCT was conducted and concluded that the intervention group showed reduced prevalence of UI with adequate levels of PFMT adherence, compared to the standard care procedure group three months after childbirth [40]. It is important to highlight that these are the few studies in women's health physiotherapy which used this approach and no studies were found specifically for the use of vaginal devices. Unfortunately, there is a small number of studies using this approach to improve women's adherence to other interventions such as vaginal dilators.
This systematic review found reports of some negative experiences of women using vaginal dilators. However, women's reports of intentionally associating the use of vaginal dilators with pleasant situations was identified as an important coping strategy that improved their experience.
The experiences reported after the use of pessaries were varied, but they underline the importance of women's participation in the process of choosing the intervention, and the essential role of the health professional in either continuity or interruption of the treatment. In the only two studies investigating pelvic floor manual interventions, women stated having had a good experience while using it, especially due to the support given by the health professional.
We must state the limitation of this systematic review reflects the limitation of the included studies. Most of the included studies had methodological shortcomes and none of those articles were excluded from the review. Nevertheless, this review brings together the experiences of women with a variety of conservative interventions, highlighting important aspects that may contribute to better healthcare assistance related to PFD and to improve both treatment adherence and satisfaction.
The results showed relevant aspects that should be considered during treatment approach (e.g., adequate communication, adequate provision of information, and appropriate support from health professionals), to particularly improve women's experience and adherence to the interventions.
This review also uncovered the need for more qualitative studies with a strong methodology to better understand women's experience with pelvic floor conservative non-pharmacological interventions, especially those regarding manual interventions and vaginal devices.

Conclusion
Women's experience with pelvic floor conservative non-pharmacological treatment options is a complex phenomenon that involves many more variables than just personal aspects. A more patient-centred approach should be considered to improve women's experience with and adherence to conservative options. See Table 4.